Aortic AneurysmNCT02669784
Computed Tomography Arteriograms (CTA) Volume Dose Reduction Study
A study testing Low Dose Contrast (Omnipaque) 40mL and Low Dose Contrast (Omnipaque) 50 mL in people with Aortic Aneurysm and Contrast Induced Nephropathy, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to determine if the dose of contrast (Omnipaque) administered for Computed Tomography Arteriograms (CTA) can be reduced without degradation of image quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Contrast Induced Nephropathy, Aortic and Arterial Anomalies
- What is being tested?
- Low Dose Contrast (Omnipaque) 40mL and Low Dose Contrast (Omnipaque) 50 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult patient scheduled for a computed tomographic arteriogram (CTA) of the chest or chest, abdomen and pelvis who had undergone a prior CTA performed with the standard contrast dose (100 mL) at this institution will be included in the study
- The follow-up scan will be routine standard of care, no emergency imaging patient will be approached for this research
Who cannot join
- Patients with no prior CTA imaging for comparison
- Any pediatric patient (age <18)
- BMI >40
- Inability to follow instructions
- Allergy to intravenous contrast
- GFR less than 30 mL/min/1.73 m2
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Does Reduction in Contrast Administration Dose in Computed Tomography Arteriograms Degrade Image Quality? A Single Institutional Review of an Ultra-low Contrast Dose Protocol
The purpose of the study is to determine if the dose of contrast (Omnipaque) administered for Computed Tomography Arteriograms (CTA) can be reduced without degradation of image quality. The hypothesis is that there is no difference in image quality using ultra-low dose contrast in CTA exams compared to routine, standard of care dose exams.
Read the detailed description
Any adult patient age 18 and above, scheduled for routine CTA (Computed Tomography Arteriograms) of the chest or chest, abdomen and pelvis meeting inclusion criteria and not meeting any exclusion criteria will be included in the study. The patient will be administered a low dose of intravenous contrast based on the study examination as described below.
CTA of the chest: 40 mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.
CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast (Omnipaque) at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.
Following the examination, the primary investigator (PI) or team members will evaluate the images obtained with low contrast dose and each patient's prior CTA examination performed with routine contrast dose, 100mL at a rate of 4mL/sec. This will be done by quantitative and qualitative measures. For the quantitative portion, the PI or team members will place regions of interest on predetermined arterial locations to obtain measure the degree of opacification. For qualitative measurement, the images will be presented in a blind fashion to two thoracic trained board certified radiologists and a board certified interventional radiologist to determine the quality of the images based on a Likert numerical scale. Qualitative and quantitative data for the images obtained with low contrast dose and those for the prior CTA examinations performed with routine contrast dose will be compared. This data along with details of the scan protocol (dose, dose rate, scanning parameters etc.) and demographic data (such as sex, age and BMI at the time of examination) will be recorded.
- Being tested
- Low Dose Contrast (Omnipaque) 40mL, Low Dose Contrast (Omnipaque) 50 mL
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Contrast (Omnipaque) 40mLDrug
The patient will be administered a low dose, 40mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec.
Low Dose Contrast (Omnipaque) 50 mLDrug
The patient will be administered a low dose, 50mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Contrast (40mL) | Active comparator | CTA of the chest: 40 mL of intravenous contrast at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. Receives: Drug: Low Dose Contrast (Omnipaque) 40mL |
| Low Dose Contrast (50mL) | Active comparator | CTA of the abdomen OR or CTA of the chest and abdomen or CTA of the abdomen and pelvis or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. Receives: Drug: Low Dose Contrast (Omnipaque) 50 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ascending Sinotubular Junction Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. Measurement was taken at the ascending aorta near the sinotubular junction.
Measured: At 30 days
Descending Thoracic Aorta Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.
Measured: 30 days
Celiac Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the proximal abdominal aorta at the level of the celiac axis.
Measured: 30 days
Burfication Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.
Measured: 30 days
Right Common Femoral Artery Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.
Measured: 30 days
Left Common Femoral Artery Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.
Measured: 30 days
CTA Vessel Opacification Grading 1
5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist.
- Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic.
- Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic.
- Moderate opacification of the lumen of the vessel. Diagnostic study.
- Good opacification of the lumen of the vessel.
- Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.
Measured: 30 days
CTA Vessel Opacification Grading 2
5 Point Grading Scale was used to determine CTA Vessel Opacification by a second Board Certified Radiologist.
- Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic.
- Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic.
- Moderate opacification of the lumen of the vessel. Diagnostic
- Good opacification of the lumen of the vessel.
- Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rekha Cherian, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669784
- Sponsor's protocol ID
- 3932
- Status last verified
- May 2019
- First submitted
- 21 Jan 2016
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Seehofnerova A, Kok M, Mihl C, Douwes D, Sailer A, Nijssen E, de Haan MJ, Wildberger JE, Das M. Feasibility of low contrast media volume in CT angiography of the aorta. Eur J Radiol Open. 2015 Apr 28;2:58-65. doi: 10.1016/j.ejro.2015.03.001. eCollection 2015.
PubMed 26937437Rubin GD. MDCT imaging of the aorta and peripheral vessels. Eur J Radiol. 2003 Mar;45 Suppl 1:S42-9. doi: 10.1016/s0720-048x(03)00036-6.
PubMed 12598026Gleeson TG, Bulugahapitiya S. Contrast-induced nephropathy. AJR Am J Roentgenol. 2004 Dec;183(6):1673-89. doi: 10.2214/ajr.183.6.01831673. No abstract available.
PubMed 15547209Vanommeslaeghe F, De Mulder E, Van de Bruaene C, Van de Bruaene L, Lameire N, Van Biesen W. Selecting a strategy for prevention of contrast-induced nephropathy in clinical practice: an evaluation of different clinical practice guidelines using the AGREE tool. Nephrol Dial Transplant. 2015 Aug;30(8):1300-6. doi: 10.1093/ndt/gfv220. Epub 2015 Jun 4.
PubMed 26047631Meschi M, Detrenis S, Musini S, Strada E, Savazzi G. Facts and fallacies concerning the prevention of contrast medium-induced nephropathy. Crit Care Med. 2006 Aug;34(8):2060-8. doi: 10.1097/01.CCM.0000227651.73500.BA.
PubMed 16763513Walsh SR, Tang T, Gaunt ME, Boyle JR. Contrast-induced nephropathy. J Endovasc Ther. 2007 Feb;14(1):92-100. doi: 10.1583/06-2035.1.
PubMed 17291156Gussenhoven MJ, Ravensbergen J, van Bockel JH, Feuth JD, Aarts JC. Renal dysfunction after angiography; a risk factor analysis in patients with peripheral vascular disease. J Cardiovasc Surg (Torino). 1991 Jan-Feb;32(1):81-6.
PubMed 2010458Diehm N, Pena C, Benenati JF, Tsoukas AI, Katzen BT. Adequacy of an early arterial phase low-volume contrast protocol in 64-detector computed tomography angiography for aortoiliac aneurysms. J Vasc Surg. 2008 Mar;47(3):492-8. doi: 10.1016/j.jvs.2007.11.004.
PubMed 18295101Viteri-Ramirez G, Garcia-Lallana A, Simon-Yarza I, Broncano J, Ferreira M, Pueyo JC, Villanueva A, Bastarrika G. Low radiation and low-contrast dose pulmonary CT angiography: Comparison of 80 kVp/60 ml and 100 kVp/80 ml protocols. Clin Radiol. 2012 Sep;67(9):833-9. doi: 10.1016/j.crad.2011.11.016. Epub 2012 Jun 8.
PubMed 22683247Wu CC, Lee EW, Suh RD, Levine BS, Barack BM. Pulmonary 64-MDCT angiography with 30 mL of IV contrast material: vascular enhancement and image quality. AJR Am J Roentgenol. 2012 Dec;199(6):1247-51. doi: 10.2214/AJR.12.8739.
PubMed 23169715
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Reduction in Contrast Administration Dose in Computed Tomography Arteriograms Degrade Image Quality? A Single Institutional Review of an Ultra-low Contrast Dose Protocol
- ClinicalTrials.gov ID
- NCT02669784
- Acronym / sponsor ID
- 3932
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Posted 11 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if the dose of contrast (Omnipaque) administered for Computed Tomography Arteriograms (CTA) can be reduced without degradation of image quality. The hypothesis is that there is no difference in image quality using ultra-low dose contrast in CTA exams compared to routine, standard of care dose exams.
Detailed description
Any adult patient age 18 and above, scheduled for routine CTA (Computed Tomography Arteriograms) of the chest or chest, abdomen and pelvis meeting inclusion criteria and not meeting any exclusion criteria will be included in the study. The patient will be administered a low dose of intravenous contrast based on the study examination as described below.
CTA of the chest: 40 mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.
CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast (Omnipaque) at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.
Following the examination, the primary investigator (PI) or team members will evaluate the images obtained with low contrast dose and each patient's prior CTA examination performed with routine contrast dose, 100mL at a rate of 4mL/sec. This will be done by quantitative and qualitative measures. For the quantitative portion, the PI or team members will place regions of interest on predetermined arterial locations to obtain measure the degree of opacification. For qualitative measurement, the images will be presented in a blind fashion to two thoracic trained board certified radiologists and a board certified interventional radiologist to determine the quality of the images based on a Likert numerical scale. Qualitative and quantitative data for the images obtained with low contrast dose and those for the prior CTA examinations performed with routine contrast dose will be compared. This data along with details of the scan protocol (dose, dose rate, scanning parameters etc.) and demographic data (such as sex, age and BMI at the time of examination) will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Contrast (40mL) | Active comparator | Drug: Low Dose Contrast (Omnipaque) 40mLCTA of the chest: 40 mL of intravenous contrast at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. |
| Low Dose Contrast (50mL) | Active comparator | Drug: Low Dose Contrast (Omnipaque) 50 mLCTA of the abdomen OR or CTA of the chest and abdomen or CTA of the abdomen and pelvis or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any adult patient scheduled for a computed tomographic arteriogram (CTA) of the chest or chest, abdomen and pelvis who had undergone a prior CTA performed with the standard contrast dose (100 mL) at this institution will be included in the study
- The follow-up scan will be routine standard of care, no emergency imaging patient will be approached for this research
Key exclusion criteria (6 listed)
- Patients with no prior CTA imaging for comparison
- Any pediatric patient (age <18)
- BMI >40
- Inability to follow instructions
- Allergy to intravenous contrast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose Contrast (Omnipaque) 40mLThe patient will be administered a low dose, 40mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec. | Drug | Low Dose Contrast (40mL) |
| Low Dose Contrast (Omnipaque) 50 mLThe patient will be administered a low dose, 50mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec. | Drug | Low Dose Contrast (50mL) |
Primary outcome
Ascending Sinotubular Junction Measurement
Time frame: At 30 days
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. Measurement was taken at the ascending aorta near the sinotubular junction.
Descending Thoracic Aorta Measurement
Time frame: 30 days
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.
Celiac Measurement
Time frame: 30 days
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the proximal abdominal aorta at the level of the celiac axis.
Burfication Measurement
Time frame: 30 days
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.
Right Common Femoral Artery Measurement
Time frame: 30 days
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.
Left Common Femoral Artery Measurement
Time frame: 30 days
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.
CTA Vessel Opacification Grading 1
Time frame: 30 days
5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist. 1. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. 2. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. 3. Moderate opacification of the lumen of the vessel. Diagnostic study. 4. Good opacification of the lumen of the vessel. 5. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.
CTA Vessel Opacification Grading 2
Time frame: 30 days
5 Point Grading Scale was used to determine CTA Vessel Opacification by a second Board Certified Radiologist. 1. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. 2. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. 3. Moderate opacification of the lumen of the vessel. Diagnostic 4. Good opacification of the lumen of the vessel. 5. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26937437Seehofnerova A, Kok M, Mihl C, Douwes D, Sailer A, Nijssen E, de Haan MJ, Wildberger JE, Das M. Feasibility of low contrast media volume in CT angiography of the aorta. Eur J Radiol Open. 2015 Apr 28;2:58-65. doi: 10.1016/j.ejro.2015.03.001. eCollection 2015.
- Background: PubMed 12598026Rubin GD. MDCT imaging of the aorta and peripheral vessels. Eur J Radiol. 2003 Mar;45 Suppl 1:S42-9. doi: 10.1016/s0720-048x(03)00036-6.
- Background: PubMed 15547209Gleeson TG, Bulugahapitiya S. Contrast-induced nephropathy. AJR Am J Roentgenol. 2004 Dec;183(6):1673-89. doi: 10.2214/ajr.183.6.01831673. No abstract available.
- Background: PubMed 26047631Vanommeslaeghe F, De Mulder E, Van de Bruaene C, Van de Bruaene L, Lameire N, Van Biesen W. Selecting a strategy for prevention of contrast-induced nephropathy in clinical practice: an evaluation of different clinical practice guidelines using the AGREE tool. Nephrol Dial Transplant. 2015 Aug;30(8):1300-6. doi: 10.1093/ndt/gfv220. Epub 2015 Jun 4.
- Background: PubMed 16763513Meschi M, Detrenis S, Musini S, Strada E, Savazzi G. Facts and fallacies concerning the prevention of contrast medium-induced nephropathy. Crit Care Med. 2006 Aug;34(8):2060-8. doi: 10.1097/01.CCM.0000227651.73500.BA.
- Background: PubMed 17291156Walsh SR, Tang T, Gaunt ME, Boyle JR. Contrast-induced nephropathy. J Endovasc Ther. 2007 Feb;14(1):92-100. doi: 10.1583/06-2035.1.
- Background: PubMed 2010458Gussenhoven MJ, Ravensbergen J, van Bockel JH, Feuth JD, Aarts JC. Renal dysfunction after angiography; a risk factor analysis in patients with peripheral vascular disease. J Cardiovasc Surg (Torino). 1991 Jan-Feb;32(1):81-6.
- Background: PubMed 18295101Diehm N, Pena C, Benenati JF, Tsoukas AI, Katzen BT. Adequacy of an early arterial phase low-volume contrast protocol in 64-detector computed tomography angiography for aortoiliac aneurysms. J Vasc Surg. 2008 Mar;47(3):492-8. doi: 10.1016/j.jvs.2007.11.004.
- Background: PubMed 22683247Viteri-Ramirez G, Garcia-Lallana A, Simon-Yarza I, Broncano J, Ferreira M, Pueyo JC, Villanueva A, Bastarrika G. Low radiation and low-contrast dose pulmonary CT angiography: Comparison of 80 kVp/60 ml and 100 kVp/80 ml protocols. Clin Radiol. 2012 Sep;67(9):833-9. doi: 10.1016/j.crad.2011.11.016. Epub 2012 Jun 8.
- Background: PubMed 23169715Wu CC, Lee EW, Suh RD, Levine BS, Barack BM. Pulmonary 64-MDCT angiography with 30 mL of IV contrast material: vascular enhancement and image quality. AJR Am J Roentgenol. 2012 Dec;199(6):1247-51. doi: 10.2214/AJR.12.8739.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose Contrast (Omnipaque) 40mL and Low Dose Contrast (Omnipaque) 50 mL in people with Aortic Aneurysm and Contrast Induced Nephropathy, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ascending Sinotubular Junction Measurement (time frame: At 30 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02669784, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.